Pain and Fatigue Assessment and Evaluation in Oncology Trials
Author(s)
Chloe Carmichael, MSc1, Sophie Van Tomme, PhD2, Harriet Makin, PhD1, Danielle Stephanie Burns, BSc, MSc3, Cécile Gousset, PharmD4, Helen Kitchen, MSc1, Jordan Miller, PhD5, Natalie Valerie Jane Aldhouse, MA1, Paul Cordero, PharmD, PhD6.
1Clarivate, London, United Kingdom, 2SANOFI, Amsterdam, Netherlands, 3Clarivate, Warrington, United Kingdom, 4Sanofi, Gentilly, France, 5Clarivate, Kirkwall, United Kingdom, 6Clinical Outcome Assesment Scientist, Sanofi, London, United Kingdom.
1Clarivate, London, United Kingdom, 2SANOFI, Amsterdam, Netherlands, 3Clarivate, Warrington, United Kingdom, 4Sanofi, Gentilly, France, 5Clarivate, Kirkwall, United Kingdom, 6Clinical Outcome Assesment Scientist, Sanofi, London, United Kingdom.
OBJECTIVES: While oncology treatments traditionally focus on survival, pain and fatigue significantly impact patients' quality of life, yet are less frequently assessed. This study aimed to review Patient Reported Outcomes (PROs) measuring these concepts and examine how key stakeholders evaluate cancer-related pain and fatigue.
METHODS: Targeted literature reviews identified PROs assessing pain and fatigue, and reviewed which were most frequently used in oncology studies with adult cancer patients. Sources included clinicaltrials.gov, FDA, EMA and HTA labels/submissions, PRO development publications, and PRO databases.
RESULTS: : PRO measures assessing pain/fatigue were identified (respectively) in 379/238 clinicaltrials.gov records, but findings were only reported in 51/12 FDA labels, 3/3 EMA labels and 66/31 HTA records (and did not necessarily impact HTA decision making or outcomes). Additional PROs specifically designed to assess pain/fatigue in oncology and not identified in clinical studies were retrieved via Ovid (n=39/n=18) and ePROVIDE (n=3/10). The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30), which assesses aspects of both pain and fatigue, was the most frequently used generic oncology PRO across both reviews. The EORTC QLQ-C30 appeared in over 200 clinical trials, was included in FDA labels and assessed in HTA submissions. However, pain and/or fatigue sub-scores were not always reported. The pain- or fatigue-specific PROs used most commonly across trials and regulatory/HTA submissions were the Brief Pain Inventory short-form (BPI-SF) and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
CONCLUSIONS: As important components of the patient experience of cancer, both pain and fatigue warrant assessment in future oncology trials. While various PROs assessing these outcomes are available, there is limited visible impact of pain and fatigue specific PRO endpoints in regulatory and HTA decision making, which may reflect the prioritisation of treatment goals for oncology products.
METHODS: Targeted literature reviews identified PROs assessing pain and fatigue, and reviewed which were most frequently used in oncology studies with adult cancer patients. Sources included clinicaltrials.gov, FDA, EMA and HTA labels/submissions, PRO development publications, and PRO databases.
RESULTS: : PRO measures assessing pain/fatigue were identified (respectively) in 379/238 clinicaltrials.gov records, but findings were only reported in 51/12 FDA labels, 3/3 EMA labels and 66/31 HTA records (and did not necessarily impact HTA decision making or outcomes). Additional PROs specifically designed to assess pain/fatigue in oncology and not identified in clinical studies were retrieved via Ovid (n=39/n=18) and ePROVIDE (n=3/10). The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30), which assesses aspects of both pain and fatigue, was the most frequently used generic oncology PRO across both reviews. The EORTC QLQ-C30 appeared in over 200 clinical trials, was included in FDA labels and assessed in HTA submissions. However, pain and/or fatigue sub-scores were not always reported. The pain- or fatigue-specific PROs used most commonly across trials and regulatory/HTA submissions were the Brief Pain Inventory short-form (BPI-SF) and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
CONCLUSIONS: As important components of the patient experience of cancer, both pain and fatigue warrant assessment in future oncology trials. While various PROs assessing these outcomes are available, there is limited visible impact of pain and fatigue specific PRO endpoints in regulatory and HTA decision making, which may reflect the prioritisation of treatment goals for oncology products.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR168
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology